Trial Information

- Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks,
in patients with painful bone metastases.

- Determine the safety of this regimen in these patients.

- Compare the change in pain interference with daily life and analgesic use at 4 weeks vs
baseline in patients treated with this regimen.

- Determine the time to recurrence of worst pain in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple
tumors may receive ablation in multiple sessions). Patients who achieve a reduction in worst
pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or
are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to
the recurring or new site.

Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are
assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks.

Patients are followed for 6 months beyond the last RFA treatment.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed bone metastases

- Pain refractory to non-opioid analgesic medication and radiotherapy OR

- Patient is considered a poor candidate for opioid analgesics or radiotherapy

- Initial worst pain score within the past 24 hours at least 4 on a scale of 0-10

- Tumors deemed accessible for radiofrequency ablation

- No evidence of impending fracture in weight-bearing bones (more than 50% loss of
cortical bone)

- Tumors must be more than 1 cm from critical structures including:

- Spinal cord, brain, or other critical nerve structures

- Large abdominal vessel (e.g., aorta or inferior vena cava)

- Bowel or bladder

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Not specified

Life expectancy:

- More than 2 months

Hematopoietic:

- Platelet count at least 75,000/mm3

Hepatic:

- INR less than 1.5

Renal:

- Not specified

Other:

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 3 weeks since prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 3 weeks since prior radiotherapy

Surgery:

- Not specified

Other:

- At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal
anti-inflammatory drugs

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